BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAMARITAN AED

    MDR report key: 788543 · Received November 17, 2006

    Report

    Report Number
    3004123209-2006-00006
    Event Type
    Other
    Date Received
    November 17, 2006
    Date of Event
    July 28, 2006
    Report Date
    November 16, 2006
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT HAS NOT BEEN RETURNED FOR EVALUATION BY THE COMPANY AT THIS DATE. ECG RECORDED DURING THE TIME OF THE EVENTS HAS BEEN ANALYZED. THE SHOCK ADVISED DECISIONS HAVE BEEN INITIALLY ASSESSED AS DUE TO ARTIFACT (SOURCE UNKNOWN AT THIS TIME). CONCERNS OF LAY USER RISK BEING ASSESSED IN RISK ANALYSIS TO BE FINALIZED WITH THE AUSTRIAN COMPETENT AUTHORITY. THIS REPORT HAS BEEN DISSEMINATED BY THE AUSTRIAN COMPETENT AUTHORITY IN COMPETENT AUTHORITY REPORT, AT-2006-11-02-001. AN INFORMATION LETTER TO CUSTOMERS HAS BEEN SENT BY THE AUSTRIAN COMPETENT AUTHORITY. HEARTSINE TECHNOLOGIES IS COOPERATING WITH THE COMPETENT AUTHORITY TO REACH A RESOLUTION REGARDING THE REPORTER'S CONCERNS OF INAPPROPRIATE TREATMENT BY NON-MEDICAL PROFESSIONALS. ADDITIONAL INFORMATION WILL BE SUBMITTED WHEN AVAILABLE AND/OR THE DEVICE HAS BEEN RETURNED FOR EVALUATION IN OUR FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE SUCCESSFUL USE OF A SAMARITAN AED (AUTOMATED EXTERNAL DEFIBRILLATOR) TO RESUSCITATE A PATIENT THE AED ADVISED SHOCKS THAT THE REPORTER THOUGHT WERE INAPPROPRIATE AND COULD POSE A RISK IF A LAY USER WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAMARITAN AED AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD SAM001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *